Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.
研究概览
简要总结
We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either injection with steroid or saline solution.
All injections are guided by ultrasonography.
详细描述
Plate Rich Plasma (PRP) is a new treatment for tendinopathy. A high concentration of blood platelets is made from the patients own blod, and then injected into the tendon. The idea is that the complex mixture of growth factors within the platelets can stimulate the healing process of the tendon. We want to address the efficacy and safety of this new treatment and compare it to either the best documented treatment, Steroid injection, or to a saline solution. We want to make a randomized controlled trial with 60 participants, 20 in each of the 3 groups, and a 12 months follow up. All injections are guided by ultrasonography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of tennis elbow > 6 months
- •Doppler activity on ultrasonography
- •Lateral elbow pain that is maximal over the lateral epicondyle, and increases with pressure on the lateral epicondyle, and resisted dorsiflexion and/or middle finger.
排除标准
- •Inflammatory disease.
- •Fibromyalgia.
- •Pain in hand or shoulder/neck in the same arm as being treated.
- •Anticoagulation treatment.
- •Wounds around the elbow.
- •Treatment with steroids within the last 3 months.
研究组 & 干预措施
Platelet Rich Plasma
干预措施: Platelet Rich Plasma (Biological)
Isotonoic Saline Solution
干预措施: Isotonic Saline Solutions (Procedure)
Steroid (Triamcinolonacetonid)
干预措施: Triamcinolonacetonid (Drug)
结局指标
主要结局
Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.
时间窗: first day, 1 months, 3 months, 6 months, 12 months.
We use the PRTEE questionaire, which is validated for tennis elbow.
次要结局
- Functional Disability(First day, 1 month, 3 months, 6 months, 12 months)
- Ultrasonographic changes(first day, 1 months, 3 months, 6 months, 12 months)
- Adverse events(through out the entire 12 months)
- Pain induced by the treatment(1 months after treatment)